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Electronic Change Management

Electronic change management helps companies speed up the production process while staying compliant.

Given the number of ongoing processes for document change to formulations, design specs, SOPs, specifications for raw materials, etc., is it any wonder that companies without electronic change management have trouble staying compliant and on target with production? Electronic change management can help.

MasterControl electronic change management software addresses the requirements of managing the change control process according to regulatory guidelines. This invariably helps when introducing, planning, and implementing changes to business processes. For many companies, compliance with regulatory standards is a necessity which is why adherence to regulations such as those established by the FDA is a top priority. MasterControl electronic change management software provides several features that allow companies to maintain compliance and a continuous state of audit-readiness.

The FDA 21 CFR Part 11 regulation emphasizes the importance of secure password management and the MasterControl solution is built to meet that requirement. And since MasterControl electronic change management software is web-based, authorized users can access the system from virtually anywhere. This also provides the facility of cross-collaboration between users situated across various regions; ultimately allowing stakeholders to initiate, discuss, and plan the changes that will shape the company's business.

MasterControl electronic change management software is designed to enable quick review and approval of documentation and ensures that vital documents are updated whenever any process goes through a change. This allows management to plan training programs that can be automatically launched as soon as a change is invoked in the system. The system's dynamic Explorers also help companies better manage their data and prevent information from slipping through the cracks.

The primary advantages of implementing the electronic change management solution offered by MasterControl are scalability and traceability. While organizations fluctuate and develop over time, industry regulations remain consistent. MasterControl is designed to offer premium change control that meets expanding needs as the organization develops and changes so that compliance can be maintained regardless of the size of the enterprise.

A primary component of a system's ability to maintain compliance is traceability. When utilizing the MasterControl system, data can be captured and then automatically transferred to highly customizable forms that ensure there is no data leakage. The same information may also be automatically directed to other quality processes such as CAPA, training, deviance, nonconformance, etc. As a result, the data entered through these forms can be easily tracked and implemented in essential business processes.

It is also important for companies to evaluate the impact of changes once they have been implemented. For this purpose, MasterControl electronic change management software provides the facility of generating timely reports that illustrate the effect of changes to existing standard operating procedures. The advanced analytics built into the software allow top level executives to evaluate if a change has been successfully implemented and the impact the change has had on the enterprise. The company can also use the system's reporting tools to measure the risks associated with change implementation so that the organization remains compliant, productive, and competitive.

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The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.